Michnar M, Milanowski J
Katedry i Kliniki Chorób Płuc i Gruźlicy, Akademii Medycznej w Lublinie.
Pneumonol Alergol Pol. 1996;64 Suppl 1:90-6.
This study was designed to examine the efficacy and tolerability of ambroxol (Ambrosol) on the symptomatology of chronic bronchitis among in- and out-patients. Seventy patients were included in the trial and divided into two random groups. The patients were treated in a double-blind way with either Ambrosol or a placebo for 2 months. The physician and the patient assessed the following points: the feeling general well-being, the symptoms of a cold and of fever, the need for treatment with antibiotics, the amount, viscosity and colour of sputurn, the difficulty in expectoration, the severity of coughing and any changes in breathlessness while at rest. In order to carry out these subjective assessments we used a scoring system. We observed that, breathlessness while at rest and the rate of exacerbation was significantly lower in the Ambrosol group after 2 weeks of therapy. Sputum viscosity, difficulty in expectoration and severity of coughing were reduced in this group after 4 or 8 weeks. Throughout the 2-month period of therapy, the tolerability of ambroxol was good. A total of 4 patients reported side-effects of various degrees of severity. One patient stopped the therapy due to these side-effects (dizziness). There was no significant difference in the number of side-effects between the two groups (Ambrosol vs Placebo).
本研究旨在探讨氨溴索（沐舒坦）对慢性支气管炎门诊和住院患者症状的疗效及耐受性。70例患者纳入试验并随机分为两组。患者采用双盲法，分别接受氨溴索或安慰剂治疗2个月。医生和患者评估以下几点：总体健康感觉、感冒和发热症状、使用抗生素治疗的必要性、痰液的量、黏稠度和颜色、咳痰困难程度、咳嗽严重程度以及静息时呼吸困难的任何变化。为了进行这些主观评估，我们使用了评分系统。我们观察到，治疗2周后，氨溴索组静息时的呼吸困难和病情加重率显著降低。4周或8周后，该组痰液黏稠度、咳痰困难程度和咳嗽严重程度降低。在整个2个月的治疗期间，氨溴索的耐受性良好。共有4例患者报告了不同严重程度的副作用。1例患者因这些副作用（头晕）停止治疗。两组（氨溴索组与安慰剂组）副作用的数量没有显著差异。
